Comply With FDA Medical Device Security Guidelines and Protect Patient Information

How to Hack Your Own Device

Hack Your Own Medical Device

The growth of data networking technology employed by hospitals to transport data throughout their facilities has dramatically improved the quality of care for patients.

Patient data is managed electronically, and ever-greater volumes of information are digitally stored, processed, and disseminated across both internal and external communication networks. On top of this, there has been growth in connections to external locations, secondary key personnel, cooperation partners, IT suppliers, and home offices for background or weekend services – all of which help guarantee interruption-free communication.

However, this advancement in data sharing brings with it additional risks—primarily, the theft of sensitive patient information and the potential malfunction of devices as a result of system or network hacking. By exploiting vulnerabilities within the software or security loopholes within the wider network, devices can be made to malfunction or stop operating, and patient data can be accessed and stolen.

This whitepaper discusses how you can better protect patients and comply with FDA guidelines that recommend that manufacturers of medical devices provide evidence that they have included cybersecurity in their risk analysis and management plans.

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Medical device cyber security

Learn from Daniel Hamburg, Ph. D., head of security engineering at TÜV Rheinland i-sec, David Surber, vice president of medical products at TÜV Rheinland Group, and Brian Nolan, practice director for Security Services at OpenSky, how IT security analysis and penetration testing can help comply with new guidelines and ensure protection of sensitive data.